The safety and tolerability of berdazimer gel 10.3% in Japanese patients with molluscum contagiosum

Abstract

Background: Molluscum contagiosum (MC) is a contagious viral skin infection. Berdazimer gel, 10.3% (SB206 12%) is approved in the United States as the first topical, at-home MC prescription medication.

Objective: To assess safety and tolerability of SB206 12% in Japanese patients with MC.

Methods: SKN15B01 (JRCT2031230123) was a phase 2, multicenter, single-group, open-label study in Japanese patients ≥2 years old with 3-70 baseline MC lesions. Patients with only periocular MC and/or immunosuppression were excluded. SB206 12% was applied once daily to lesions for 12 weeks. Safety endpoints included adverse events and local skin reactions. Exploratory efficacy endpoints included percentage of patients with complete lesion clearance and lesion count percent change from baseline.

Results: Twenty patients (12 males, 8 females) with mean (range) age of 5.2 (3-13) years and mean (range) baseline lesion counts of 22.5 (8-44). Complete clearance and percent change from baseline at week 12 were 60% and -89.2%, respectively. The most common treatment-related adverse events were application site-erythema (25%, n = 5), -pain (25%, n = 5), -pruritis (25%, n = 5), and -dermatitis (20%, n = 4), all mild/moderate in severity.

Limitations: Single-group study; small sample size.

Conclusion: Safety and efficacy of berdazimer gel, 10.3% in Japanese patients were favorable and consistent with previous studies.

Keywords: Japanese patients; berdazimer gel; molluscum contagiosum; nitric oxide.

Fig 1

Molluscum contagiosum. Percentage of patients treated with berdazimer gel, 10.3% (N = 20) who had complete clearance of all molluscum contagiosum lesions.

Fig 2

Molluscum contagiosum. Percent change in molluscum contagiosum lesion count from baseline in patients treated with berdazimer gel, 10.3% (N = 20).

Fig 3

Molluscum contagiosum. Clinical courses of 4 Japanese patients with molluscum contagiosum treated with berdazimer gel, 10.3%. A, Arm lesions; (B) trunk lesions; (C) arm flexural lesions; (D) axilla lesions. Bar below photos indicates treatment regimen throughout the study, with green representing application to all lesions; orange representing application withheld; yellow indicating application to specific lesions, and red text indicates the day when complete clearance was observed by the investigator.

Fig 3

Molluscum contagiosum. Clinical courses of 4 Japanese patients with molluscum contagiosum treated with berdazimer gel, 10.3%. A, Arm lesions; (B) trunk lesions; (C) arm flexural lesions; (D) axilla lesions. Bar below photos indicates treatment regimen throughout the study, with green representing application to all lesions; orange representing application withheld; yellow indicating application to specific lesions, and red text indicates the day when complete clearance was observed by the investigator.